Variations to Marketing Authorisations

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

2-3 Oct 2019

& 2-3 Apr 2020 , 8-9 Oct 2020

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

The course will cover the latest variation regulations and offer guidance from an industry expert on how to optimise your regulatory procedures to help achieve faster approval.

Benefits of attending:

  • Gain an overview of the EU system for variations
  • Assess how pharma companies are working in this evolving regulatory environment
  • Profit from practical advice on the preparation and submission of variation applications
  • Understand the impact of Module 3 on your variations dossier
  • Discuss filing tips and strategies to help achieve faster approval

Who should attend?

This course will be particularly relevant for those working in registration and regulatory affairs. It will also be of interest to anyone with an involvement in the variations process including QA, clinical safety and pharmacovigilance personnel.

Day one

Basis of EU Regulations 1234/2008 and 712/2012

  • Classification in accordance with the legislation
  • Understand the differences between type lA, type IB and type ll variations
  • Clarify foreseen and unforeseen variations

Special topics in variations

  • Handling active ingredient master files as variations
  • Submission of new clinical data

Practical session: Analysing and classifying the different changes
Grouping and work-sharing

  • Understanding when grouping is appropriate
  • Clarifying what types of variations may be grouped
  • Guidance on assembling a grouped submission
  • Understanding when work-sharing is appropriate

Understanding Module 3

  • The dossier impact on variations
  • QbD
  • CQA pyramids

Practical session: Understanding reviewers
Filing strategy

  • Creating a global dossier (gold/silver/ bronze versions)
  • Understanding implementation and grace periods
  • Fixed and rolling implementation strategy

Practical session: Plan the timelines/project management of a variation submission

Day two

Other procedures

  • Article 5
  • Urgent safety restrictions
  • Understanding when to use extension applications

Filing tips

  • Submitting type IA, IB and type II applications
  • Understand how to ensure that your dossier is complete
  • Find out what to do when your application is rejected

Submission planning

  • Identify and understand strategic considerations

Data requirements for type II variations

  • Learn how to identify and support a type II change

Practical exercise: Data requirements for more complex changes
Variations through national procedures and differences from centralised procedure

  • Understand the procedures
  • Languages and translations
  • Explore the linguistic review process

Mutual recognition and decentralised procedures for variations

  • Understand the procedures and responsibilities of the MAH, RMS and CMS
  • Learn how to efficiently plan for and run an MR variation procedure

Practical exercise: A variation to an example MRP authorised product including planning timelines and impact of referrals
Advanced compliance

  • Creating your own compliance requirements
  • SUPAC guidance

Presenters

Andrew Willis

An independent consultant with 32 years of experience with regulatory affairs and pharmaceutical development. Experience at multiple levels within pharmaceutical companies and most recently as Vice President for Regulatory Affairs, gaining significant experience in co-ordinating, planning and running global development projects.

His experience is wide ranging, allowing fast, effective development of medicinal products, through early stages, through registration and continued Life Cycle Management.

Since acting as an independent consultant his roles have included:
  • Interim Strategic advice to major pharmaceutical company for roll-out and compliance strategies for Russia / CIS, MENA, ASEAN, LATAM, South Africa and Switzerland, including ensuring appropriate staff development and strategies which ensure protection of intellectual property whilst maintain patient focus.
  • Orphan drug registrations of vaccine products and synthetic molecules
  • NCE approved in US and Europe for urology product (Simultaneous NDA and EU Centralised submission)
  • Support for NBE during clinical phases and CMC support for a Biosimilar, Biosimilar / Biologic CMC reviewer for major pharma. Biosimilar experience includes working on first EU biosimilar onwards.
  • Oversight of Regulatory strategy for ATMP (Cancer vaccine) and CMC lead for Stem Cell treatment
  • Training to major pharmaceutical companies for Chemistry and Pharmacy section of the dossier and Life Cycle Management. Additional lead training / presentations on Life Cycle Management for TOPRA.

Furthermore, his responsibilities have provided senior management oversight and direction in the following key areas: -

  • Strategic management of ATMP products for Biotech start-up company
  • Strategic Biosimilar team, developing a global biotech and biosimilar strategy for key biosimilar products.
  • Global Quality Leadership Team, providing oversight and direction for global quality processes.
  • Innovation Team, providing oversight and direction for the innovation.

Additional experiences reflect raising funds for new start-up companies and associated due diligence activities. Also he has substantial awareness of management of P & L performance, growth initiatives related to service expansion, geographical expansion and innovative business development approaches.

Andrew Willis

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.

He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.

Book now

2-3 Oct 2019
2-3 Oct 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
2-3 Apr 2020
2-3 Apr 2020 Rembrandt Hotel, London GBP 1,499.00
USD 2,099.00
EUR 2,338.00
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.
8-9 Oct 2020
8-9 Oct 2020 Venue not yet confirmed
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

Previous customers include...

  • Abbott Healthcare Products BV
  • Archimedes Pharma UK Limited
  • Avon Automotive plc
  • Bayer Healthcare
  • BOC Ltd (part of the Linde Group)
  • Bristows LLP
  • Fresenius Kabi UK Ltd
  • Galderma (UK) Limited
  • Galen Ltd
  • GRUNENTHAL NV
  • Ipsen Biopharm Ltd
  • Janssen-Cilag Ltd
  • Lundbeck Limited
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Milpharm Ltd/Aurobindo Pharma Limited
  • Mylan
  • Perrigo Israel Pharmaceuticals Ltd
  • Pierre Fabre Ltd
  • Ranbaxy Laboratories Ltd
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Roche Products Ltd
  • Rosemont Pharmaceuticals Limited
  • S A Consultancy Ltd
  • Shire Pharmaceutical Ltd
  • SHORE LTD
  • Sinclair IS Pharmaceuticals Ltd
  • Teva UK Ltd
  • Torbay Pharmaceuticals
  • Waymade Plc
  • Wrafton Laboratories Ltd, t/a Perrigo